Product Information

Supporting Documents

February 27, 2015 Approval Letter - RotarixTo include product labeling to indicate that the diluent in oral applicators should be stored at 2-8°C or at controlled room temperature up to 25°C instead of the current recommendation for storage at 20-25°C.

May 1, 2014 Approval Letter - RotarixTo include a summary of post-marketing surveillance data suggestive of an increased risk of intussusception in the 7 days following dose 2 of Rotarix.

December 30, 2009 Approval Letter - RotarixRevision: To include a contraindication for demonstrated history of hypersensitivity to the vaccine or any components of the vaccine, in the Warning and Precautions section.

April 3, 2008 Approval Letter - RotarixIndication: Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6-24 weeks.

Related Information

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